Teva receives EU nod for Neulasta biosimilar

August 13, 2013 1:41 PM

Teva Pharmaceuticals announced last week that the European Commission has granted marketing authorization for Lonquex (lipegfilgrastim).

Lonquex is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) with the active ingredient lipegfilgrastim – a novel glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex (lipegfilgrastim) is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). Lonquex is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

“This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer” said Dr. Rob Koremans, President and CEO of Teva Specialty Medicines. “Lonquex is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy. The European approval comes earlier than expected, just 8 weeks after the positive CHMP opinion. We look forward to providing this oncology supportive care treatment option in all European Union member states.”

Lonquex has undergone a full clinical development program, including pre-clinical to clinical in vivostudies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.

Dr. Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer, commented: “Effective prevention and treatment of febrile neutropenia is an important consideration for clinicians managing cancer patients who are undergoing cytotoxic chemotherapy. As well as targeting cancer cells, chemotherapy affects rapidly-dividing bone marrow cells, thereby dramatically reducing a patient’s ability to fight off infection, with potentially serious consequences. This approval is testament to Teva’s commitment to bringing new and alternative treatments to market to support clinicians in caring for patients.”

Teva, the Israeli company is investing on biosimilars for several years. The company refers to Lonquex as a “biobetter” although the product was shown only non-inferior to Neulasta, Amgen’s original drug.

Teva already markets a biosimilar version of Neupogen (filgrastim) in Europe, together with Sandoz and Hospira. But with this new approval, Teva gains a big advantage against competitors. The company has also received the approval of biosimilar filgrastim in the US and according to reports, it intends to market the product before the end of 2013.

 

Source: Teva

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